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U.S. Department of Health and Human Services

Regulatory Information

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Navigate the Regulatory Information Section

Legislation

The Food and Drugs Act of 1906 and other congressional milestones are presented in this section.

Rules & Regulations

Rules and regulations help FDA ensure that regulated products are safe and effective.

Guidances

Guidances represent FDA's current thinking on a topic. They do not create/confer rights or bind FDA or the public.

Dockets Management

Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDA

Freedom of Information

Electronic reading rooms contain publicly releasable agency records and other information routinely made available.

Standards

FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.

 
 
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Regulations and Rulemaking

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